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Rituximab Adds Survival Advantage to Fludarabine/Cyclophosphamide for CLL

Rituximab Adds Survival Advantage to Fludarabine/Cyclophosphamide for CLL

HOUSTON—Adding rituximab (Rituxan) to fludarabine
(Fludara)/cyclophosphamide (Cytoxan, Neosar) (FCR) prolongs survival in
patients with relapsed chronic lymphocytic leukemia (CLL), according to
Guillermo Garcia-Manero, MD. Dr. Garcia-Manero is assistant professor in the
Department of Leukemia at The University of Texas M. D. Anderson Cancer
Center in Houston. He presented updated data on this study in a poster at
the 43rd Annual Meeting of the American Society of Hematology.

During course 1, rituximab was given at a slow rate at 375 mg/m² on day 1
followed by fludarabine at 25 mg/m² and cyclophosphamide at 250 mg/m² on days 2-4. During subsequent
courses (2-6), rituximab was given at 500 mg/m² on day 1 and fludarabine
and cyclophosphamide, which were given at the same doses, were given on days

Data on Previously Treated CLL Patients

Dr. Garcia-Manero presented data on 136 patients with previously treated
CLL. These included 4 with Rai stage 0, 35 with stage I, 26 with stage II,
19 with stage III, and 52 with stage IV disease. Patients had a median of
2.5 previous treatments (range: 1-10). Median platelet count at baseline
was 116.5 × 109/L (range: 6-388 × 109/L); median hemoglobin was 12.1 g/dL
(range: 6.8-16.5 g/dL); and median white blood count was 51.9 × 109/L
(range: 1.3-583 × 109/L). Sixty percent of patients had three or more
lymph node sites involved.

Using National Cancer Institute (NCI) criteria, Dr. Garcia-Manero
reported 28 (21%) complete responses (CR), 18 (13%) nodular partial
responses (nPR), and 50 (37%) partial responses (PR), for an overall
response rate (ORR) of 71%. Five of 14 patients (35%) who had immunoglobulin
rearrangements detectable by polymerase chain reaction (PCR) assay at study
entry had molecular complete responses (PCR negative) after treatment.
Responses varied depending on prior therapy (see Table 1).

Rituximab Combination Prolongs Survival

Compared to historical data on CLL patients treated with
fludarabine/cyclophosphamide, the FCR combination prolonged survival (see
Figure 1). Adding rituximab increased not only the ORR but the proportion of
those responses that were complete remissions, according to Dr. Garcia-Manero.


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